The purpose of this study is to assess whether ChimeriVax™ JE vaccine (a new vaccine to be used for vaccination against Japanese encephalitis) is safe and well tolerated when compared to placebo (dummy) vaccination.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
2,004
0.5 mL, Subcutaneous
0.5 mL, Subcutaneous
Unnamed facility
Burbank, California, United States
Unnamed facility
Costa Mesa, California, United States
Number of Participants Reporting Treatment Related Adverse Events Post Vaccination With Either ChimeriVax™-JE or a Placebo
Adverse events were collected by means of diary cards and scripted interviews. All adverse events reporting was considered "actively solicited" through Day 30.
Time frame: Day 0 up to 30 days post-vaccination
Number of Participants Reporting Treatment Emergent Local Adverse Reactions and Treatment Emergent Systemic Reactions Post-vaccination With Either ChimeriVax™-JE or a Placebo
Treatment emergent local adverse reactions: Injection Site Pain, Itching, Erythema, Swelling, Induration, Skin Rash, and others as reported. Treatment emergent systemic reactions: Malaise, Headache, Myalgia, Feeling Hot, Chills, Fatigue, Dyspnea, Wheezing, Nausea, Vomiting, Diarrhea, Abdominal Pain and others as reported.
Time frame: Day 0 up to 30 days post-vaccination
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Unnamed facility
Davis, California, United States
Unnamed facility
San Francisco, California, United States
Unnamed facility
Vallejo, California, United States
Unnamed facility
Miami, Florida, United States
Unnamed facility
Orlando, Florida, United States
Unnamed facility
Pembroke Pines, Florida, United States
Unnamed facility
Iowa City, Iowa, United States
Unnamed facility
Overland Park, Kansas, United States
...and 12 more locations